- Biologics License Application (BLA) for
efgartigimod in generalized myasthenia gravis (gMG) on track to be
submitted to U.S. Food and Drug Administration (FDA) by
end of 2020 -
- Global Phase 3 ADDRESS trial evaluating
subcutaneous (SC) efgartigimod in pemphigus patients on track to
initiate by end of 2020 -
- Decision to continue ADHERE trial beyond first
30 patients in chronic inflammatory demyelinating polyneuropathy
(CIDP) now expected in first half of 2021 -
-
Management to host conference call today at 2:30 pm CEST (8:30 am
ET) -
October 22, 2020 Breda,
the Netherlands / Ghent, Belgium – argenx (Euronext &
Nasdaq: ARGX), a global immunology company committed to improving
the lives of people suffering from severe autoimmune diseases and
cancer, today announced its financial results for the third quarter
ended September 30, 2020 and provided a business update.
“It has been an important year for argenx,
marked by a number of significant achievements that position us to
file our first BLA for efgartigimod as a new treatment for gMG by
year-end. We remain focused on both the BLA filing and commercial
preparations as we work to bring efgartigimod to patients as soon
as possible,” said Tim Van Hauwermeiren, CEO of argenx. “We have
built an exceptional team, established our global supply chain and
connected with physicians, payors and patient advocacy groups – all
critical elements for a successful commercial launch.”
“We are building a broad FcRn antagonist program
by leveraging the potential of efgartigimod across a number of
important indications where there is a high unmet need for
innovation. Our global Phase 3 ADDRESS trial in pemphigus is on
track to start soon and, as we did with the ADAPT trial in MG, we
have carefully designed the trial alongside patients and physicians
to best address the complex challenges presented by this serious
disease. We continue to ground our pipeline expansion strategy in
biology, working from the science to address severe autoimmune
diseases and advance our ‘argenx 2021’ vision across our emerging
franchises,” continued Mr. Van Hauwermeiren.
THIRD QUARTER 2020 AND RECENT BUSINESS
UPDATE
Preparations underway to support
potential approval and launch of FcRn antagonist, efgartigimod, in
gMG in U.S., Japan and EU
- BLA on track to be filed with the FDA by the end of 2020 with
an expected U.S. commercial launch in 2021
- Japanese Marketing Authorization Application (J-MAA) expected
to be filed with the Pharmaceuticals and Medical Devices Agency
(PMDA) in the first half of 2021 with an anticipated Japan
commercial launch in 2022
- Regulatory filing in the EU to follow filing in Japan
- Pre-commercial launch activities underway, including global
supply chain creation, and physician, payor and patient advocacy
engagement
Presented supportive data from global
Phase 3 ADAPT trial of efgartigimod in gMG at recent medical
meetings, showing rapid and clinically meaningful responses to
efgartigimod and a safety profile comparable to
placebo
- Results from Phase 3 ADAPT trial presented at Myasthenia Gravis
Foundation of America (MGFA) 2020 Virtual Scientific Session and
American Association of Neuromuscular & Electrodiagnostic
Medicine (AANEM) 2020 Virtual Annual Meeting were consistent with
previously announced positive topline results
- New data analyses presented on significant magnitude and
repeatability of response, clinical benefit in antibody-negative
patients and validation of proposed mechanism of action, with
notable reductions in total IgG and pathogenic autoantibody
levels
Broad efgartigimod development plan
progressing with Phase 2 trial of fifth indication expected to
start in mid-2021
- Within neuromuscular franchise, efgartigimod is being developed
for gMG and CIDP
- FDA discussions to occur by end of 2020 to inform bridging
strategy for SC efgartigimod for the treatment of gMG
- Path forward to be communicated after alignment with FDA
- Phase 2 ADHERE trial of SC efgartigimod for the treatment of
CIDP is ongoing
- Decision to expand trial after analysis of first 30 patients
now expected in first half of 2021 due to enrollment delays caused
by COVID-19
- Within hematology franchise, efgartigimod is being developed
for primary immune thrombocytopenia (ITP)
- Communication with FDA planned to discuss development of SC
efgartigimod
- Updated plan for registration program to include two trials to
run concurrently
- ADVANCE trial ongoing in up to 156 patients treated with IV
efgartigimod
- ADVANCE-SC trial expected to start by end of 2020 in up to 156
patients treated with SC efgartigimod
- argenx is advancing development of efgartigimod for pemphigus
(vulgaris and foliaceus)
- Global Phase 3 ADDRESS trial evaluating SC efgartigimod in up
to 150 pemphigus patients to initiate by end of 2020
- Trial to evaluate efficacy and safety, including potential to
drive fast onset of disease control and complete remission and the
ability to taper corticosteroids
- Preparations underway to initiate Phase 2 trial in fifth rare
disease indication by mid-2021
- Indication details, including on biology rationale, Phase 2
trial design and commercial opportunity, to be shared during
investor event in first half of 2021
Development of cusatuzumab ongoing as
potential treatment for acute myeloid leukemia (AML) and
higher-risk myelodysplastic syndromes (MDS) as part of global
collaboration and licensing agreement with Cilag GmbH
International, an affiliate of Janssen
- Ongoing trials under collaboration include:
- Phase 2 CULMINATE trial of cusatuzumab in combination with
azacitidine in newly diagnosed, elderly patients with AML who are
ineligible for intensive chemotherapy
- Phase 1b ELEVATE trial of cusatuzumab in combination with
venetoclax +/- azacitidine in newly diagnosed, elderly patients
with AML who are ineligible for intensive chemotherapy
- Phase 1 trial in Japan of cusatuzumab in combination with
azacitidine evaluating newly diagnosed, elderly AML patients who
are ineligible for intensive chemotherapy
- Topline data from CULMINATE trial are anticipated to be
reported in early 2021
Initiated Phase 1 healthy volunteer
study of IV and SC ARGX-117 targeting complement C2
- Data from Phase 1 healthy volunteer study expected in
mid-2021
- Following analysis of Phase 1 data, argenx plans to launch
Phase 2 proof-of-concept trials in severe autoimmune diseases,
including multifocal motor neuropathy (MMN)
- Single-center Phase 1 trial remains open for enrollment to
evaluate ARGX-117 as a potential treatment for acute respiratory
distress syndrome (ARDS), a frequent and serious complication
associated with COVID-19
Continued
investment in Immunology Innovation Program to build pipeline of
first-in-class antibodies against immunologic targets
- New partnerships announced with Chugai and the Clayton
Foundation to expand argenx’s access to innovative antibody
engineering technologies and to enhance its capabilities to build
future antibody candidates with sweeping and half-life extending
characteristics
- Collaboration with Halozyme for ENHANZE® drug delivery
technology expanded to include three additional exclusive targets
upon nomination bringing the total to six potential targets
Q3
2020 FINANCIAL RESULTS
|
|
Nine Months Ended |
|
|
|
|
|
September 30, |
|
|
|
(in thousands of € except for shares and EPS) |
|
2020 |
|
2019 |
|
Variance |
Revenue |
|
€ |
30,062 |
|
€ |
52,264 |
|
€ |
(22,202) |
Other operating income |
|
|
12,524 |
|
|
8,914 |
|
|
3,610 |
Total operating
income |
|
|
42,586 |
|
|
61,178 |
|
|
(18,592) |
Research and development
expenses |
|
|
(246,284) |
|
|
(122,800) |
|
|
(123,484) |
Selling, general and
administrative expenses |
|
|
(100,380) |
|
|
(41,734) |
|
|
(58,646) |
Total operating
expenses |
|
|
(346,664) |
|
|
(164,534) |
|
|
(182,130) |
Change in fair value on
non-current financial assets |
|
|
1,076 |
|
|
— |
|
|
1,076 |
Operating
loss |
|
€ |
(303,002) |
|
€ |
(103,356) |
|
€ |
(199,646) |
Financial
income/(expenses) |
|
|
(1,683) |
|
|
10,789 |
|
|
(12,472) |
Exchange gain/(losses) |
|
|
(55,896) |
|
|
26,943 |
|
|
(82,838) |
Loss before
taxes |
|
€ |
(360,581) |
|
€ |
(65,624) |
|
€ |
(294,956) |
Income taxes |
|
€ |
(2,715) |
|
€ |
(4,433) |
|
€ |
1,718 |
Loss for the period
and total comprehensive loss |
|
€ |
(363,296) |
|
€ |
(70,057) |
|
€ |
(293,238) |
Weighted average number of
shares outstanding |
|
|
44,717,568 |
|
|
37,882,282 |
|
|
|
Basic and diluted
profit/(loss) per share (in €) |
|
|
(8.12) |
|
|
(1.85) |
|
|
|
Net increase in cash, cash equivalents and current financial
assets compared to year-end 2019 |
|
|
468,223 |
|
|
358,679 |
|
|
|
Cash, cash equivalents and current financial assets at the end
of the period |
|
|
1,804,043 |
|
|
923,248 |
|
|
|
DETAILS OF THE FINANCIAL
RESULTS
Cash, cash equivalents and current financial
assets totaled €1,804.0 million on September 30, 2020, compared to
€1,335.8 million on December 31, 2019. The increase in cash and
cash equivalents and current financial assets resulted primarily
from the closing of a global offering, including a U.S. offering
and a European private placement, which resulted in the receipt of
€730.7 million in net proceeds in June 2020, and net cash flows
used in operating activities.
Total operating income decreased by €18.6
million for the nine months ended September 30, 2020 to €42.6
million, compared to €61.2 million for the nine months ended
September 30, 2019. The decrease was due to the milestone payments
following the first-in-human clinical trial with ABBV-115 under the
AbbVie collaboration which was achieved in the nine months ended
September 30, 2019. This was partly offset by higher revenue
recognition of the transaction price related to the Janssen
collaboration and the increase in other income driven by higher
payroll tax rebates for employing certain research and development
personnel.
Research and development expenses increased by
€123.5 million for the nine months ended September 30, 2020 to
€246.3 million, compared to €122.8 million for the nine months
ended September 30, 2019. The increase in the first nine months of
2020 resulted primarily from higher external research and
development expenses, primarily related to the efgartigimod program
in various indications, the cusatuzumab program and other clinical
and preclinical programs. Furthermore, the personnel expenses
increased due to a planned increase in headcount.
Selling, general and administrative expenses
totaled €100.4 million for the nine months ended September 30,
2020, compared to €41.7 million for the nine months ended September
30, 2019. The increase resulted primarily from higher personnel
expenses and consulting fees related to the preparation of a
possible future commercialization of argenx’s lead product
candidate efgartigimod.
For the nine months ended September 30, 2020,
financial expenses, which primarily relate to interest received and
changes in fair value of current financial assets, amounted to €1.7
million, compared to a financial income of €10.8 million for the
nine months ended September 30, 2019. Financial expenses
corresponded mainly to a decrease in net asset value of current
financial assets following the impact of the COVID-19 outbreak on
the financial markets.
Exchange losses totaled €55.9 million for the
nine months ended September 30, 2020, compared to an exchange gain
of €26.9 million for the nine months ended September 30, 2019. The
change is mainly attributable to unrealized exchange rate losses on
the cash, cash equivalents and current financial asset position in
U.S. dollars.
EXPECTED 2021 FINANCIAL
CALENDAR:
- March 4, 2021: FY 2020 financial results and business
update
- May 13, 2021: Q1 2021 financial results and business
update
- July 29, 2021: HY 2021 financial results and business
update
- October 28, 2021: Q3 2021 financial results and business
update
CONFERENCE CALL DETAILSThe
third quarter 2020 results and business update will be discussed
during a conference call and webcast presentation today at 2:30 pm
CEST/8:30 am ET. A webcast of the live call may be accessed on the
Investors section of the argenx website at argenx.com/investors. A
replay of the webcast will be available on the argenx website.
Dial-in numbers:Please dial in
15 minutes prior to the live call.
Belgium
0800 389 13 France
0805 102 319 Netherlands
0800 949 4506 United Kingdom
0800 279 9489 United
States
1 866 270
1533International
1 412 317 0797
About argenxargenx is a global
immunology company committed to improving the lives of people
suffering from severe autoimmune diseases and cancer. Partnering
with leading academic researchers through its Immunology Innovation
Program (IIP), argenx aims to translate immunology breakthroughs
into a world-class portfolio of novel antibody-based medicines.
argenx is evaluating efgartigimod in multiple serious autoimmune
diseases, and cusatuzumab in hematological cancers in collaboration
with Janssen. argenx is also advancing several earlier stage
experimental medicines within its therapeutic franchises. argenx
has offices in Belgium, the United States, and Japan. For more
information, visit www.argenx.com and follow us on LinkedIn at
https://www.linkedin.com/company/argenx/.
For further information, please contact:
Beth DelGiacco, Vice President, Corporate Communications &
Investor Relations +1 518 424 4980bdelgiacco@argenx.com
Joke Comijn, Director Corporate Communications & Investor
Relations (EU)+32 (0)477 77 29 44+32 (0)9 310 34
19jcomijn@argenx.com
Forward-looking Statements
The contents of this announcement include
statements that are, or may be deemed to be, “forward-looking
statements.” These forward-looking statements can be identified by
the use of forward-looking terminology, including the terms
“believes,” “estimates,” “anticipates,” “expects,” “intends,”
“may,” “will,” or “should” and include statements argenx makes
concerning its 2020 business and financial outlook and related
plans; the therapeutic potential of its product candidates;
the intended results of its strategy and argenx’s, and its
collaboration partners’, advancement of, and anticipated clinical
development, data readouts and regulatory milestones and plans,
including the timing of planned clinical trials and expected data
readouts; the design of future clinical trials and the timing and
outcome of regulatory filings and regulatory approvals. By
their nature, forward-looking statements involve risks and
uncertainties and readers are cautioned that any such
forward-looking statements are not guarantees of future
performance. argenx’s actual results may differ materially from
those predicted by the forward-looking statements as a result of
various important factors, including the effects of the COVID-19
pandemic, argenx’s expectations regarding its the inherent
uncertainties associated with competitive developments, preclinical
and clinical trial and product development activities and
regulatory approval requirements; argenx’s reliance on
collaborations with third parties; estimating the commercial
potential of argenx’s product candidates; argenx’s ability to
obtain and maintain protection of intellectual property for its
technologies and drugs; argenx’s limited operating history; and
argenx’s ability to obtain additional funding for operations and to
complete the development and commercialization of its product
candidates. A further list and description of these risks,
uncertainties and other risks can be found in argenx’s U.S.
Securities and Exchange Commission (SEC) filings and reports,
including in argenx’s most recent annual report on Form 20-F filed
with the SEC as well as subsequent filings and reports filed by
argenx with the SEC. Given these uncertainties, the reader is
advised not to place any undue reliance on such forward-looking
statements. These forward-looking statements speak only as of the
date of publication of this document. argenx undertakes no
obligation to publicly update or revise the information in this
press release, including any forward-looking statements, except as
may be required by law.
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